UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061552 |
|---|---|
| Receipt number | R000070223 |
| Scientific Title | FLower strategy Outcomes With pulsed-field Energy foR Atrial Fibrillation |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/13 13:08:57 |
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Basic information
Public title
Efficacy and Safety of Flower-Only Catheter Strategy Using Pulsed Field Ablation in Patients with Persistent Atrial Fibrillation
Acronym
PFA Flower Strategy Study
Scientific Title
FLower strategy Outcomes With pulsed-field Energy foR Atrial Fibrillation
Scientific Title:Acronym
FLOWER-AF Study
Region
| Japan |
Condition
Condition
Persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to demonstrate that pulmonary vein isolation and left atrial posterior wall isolation using flower and olive configurations for pulsed-field ablation (PFA) in persistent atrial fibrillation is non-inferior to the conventional approach using basket, flower, and olive configurations, and is associated with less hemolysis and acute kidney injury.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of atrial fibrillation at 6 to 12 months after treatment
Key secondary outcomes
Degree of hemolysis (changes in haptoglobin, free hemoglobin, direct bilirubin, LDH, creatinine, and hemoglobin levels before PFA, immediately after PFA, and on the following day)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional method (basket, flower, and olive configurations)
Interventions/Control_2
Flower strategy (flower and olive configurations only)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing PFA for persistent atrial fibrillation
Key exclusion criteria
1. Patients who have expressed refusal to participate in this study
2. Patients deemed inappropriate for participation by the attending physician
3. Patients on hemodialysis and patients with cardiomyopathy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Takemoto |
Organization
Steel Memorial Yawata Hospital
Division name
Cardiovascular Center
Zip code
8058508
Address
1-1-1 Haruno-machi, Yahatahigashi-ku, Kitakyushu
TEL
093-672-3176
matakemo@outlook.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Shimono |
Organization
Steel Memorial Yawata Hospital
Division name
Cardiovascular Center
Zip code
8058508
Address
1-1-1 Haruno-machi, Yahatahigashi-ku, Kitakyushu
TEL
0936723176
Homepage URL
matakemo@outlook.jp
Sponsor or person
Institute
Steel Memorial Yawata Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Steel Memorial Yawata Hospital
Address
1-1-1 Haruno-machi, Yahatahigashi-ku, Kitakyushu
Tel
0936723176
shimono.s@ns.yawata-mhp.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070223
